Kornimate/medical-research-clean huggingface dataset:
effects of amp application after non-surgical periodontal therapy on treatment of periodontitis

Conditions: Periodontitis

Summary: chronic periodontitis is an infectious disease of periodontal support tissues caused by bacterial biofilm, which leads to inflammation and destruction of periodontal support tissues ultimately resulting in tooth loss.in the clinic, patients with stage iii and grade b periodontitis are difficult to gain desired outcomes on account of deep periodontal pockets, complicated anatomy, the removal of subgingival dental biofilms, and control of residual inflammation. a large number of studies have indicated that the effectiveness of local application of antibiotics as an adjunct to scaling and root planning (srp), such as the antimicrobial and minocycline hydrochloride could affect bacterial metabolism and inhibit bioﬁlm attachment particularly in terms of pocket depth reduction and attachment level gain. however, the use of wide-spectrum antibiotics may cause some inevitable side effects including drug resistance, pathogens and probiotics were eliminated leading to diversity of microbiota diminished, and toothstaining. to solve the problems of antibiotics in the clinic, antimicrobial peptides (amps) may be considered as an alternative to conventional antibiotics drugs.in this randomized clinical trial, we aimed to evaluate the effects of amps as an addition to srp on clinical parameters and microbiological biofilms in patients with stage iii and grade b periodontitis.


Eligibility criteria:
inclusion criteria: * at least 18 years old * previously untreated stage iii and grade b periodontitis by clinically and radiologically。in 2018, eep and aap sorted out periodontitis into four classifications (stage i to iv) based on several variables including clinical attachment loss, amount and percentage of bone loss, probing depth, presence and extent of angular bony defects and furcation involvement, tooth mobility, and tooth loss due to periodontitis, and three levels (grade a: low risk, grade b: moderate risk, grade c: high risk of progression) according to the rate of disease progression. * a minimum of 20 natural teeth in the mouth, and more than 4 molars. exclusion criteria: * acute oral lesions or necrotizing ulcerative periodontitis, * having received antibiotics within 6 months or the need for antibiotic coverage during experiment, * being allergic to minocycline, * no orthodontic treatment, * a history of systemic diseases, * pregnancy, * smoker
an open-label dose escalation/expansion trial to evaluate the safety and anti-tumor activity of tev-56278 alone or in combination with pembrolizumab in participants with advanced or metastatic solid tumors

Conditions: Advanced Solid Tumors

Summary: the primary objectives of this trial are to: * characterize the safety and tolerability of tev-56278 * determine the recommended phase 2 dose (rp2d) * evaluate antitumor activity of tev-56278 * determine the safety and tolerability of tev-56278 in combination with pembrolizumab * determine a rp2d of tev-56278 in combination with pembrolizumab the secondary objectives of this trial are to: * characterize the serum pharmacokinetics of tev-56278 * evaluate the antitumor activity of tev-56278 * determine the safety and tolerability of tev-56278 * evaluate other measures of antitumor activity of tev-56278 * evaluate anti-tumor activity participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. the total duration of the trial will be up to 25 months for individual participants.


Eligibility criteria:
inclusion criteria: * have an established histological diagnosis of selected solid tumor and must have received and progressed on established standard therapies or have been intolerant to such therapy or have been considered by the investigator as ineligible for approved standard therapy * have a life expectancy≥12 weeks at the time of the screening * women of childbearing potential must agree to use highly effective methods of contraception for the course of the trial through 120 days after the last dose of trial medication * males who are sexually active with women of childbearing potential must agree to use condoms and refrain from donating sperm for the course of the trial through 120 days after the last dose of trial medication note- additional criteria apply, please contact the investigator for more information exclusion criteria: * has a history of systemic treatment therapy for cancer (including chemotherapy, immunotherapy, radiotherapy, or other investigational drug) or surgery within 4 weeks prior to baseline * is currently receiving or has received hematopoietic colony-stimulating growth factors within 2 weeks before screening or transfusion support 4 weeks prior to screening * has a diagnosis of immunodeficiency * has active known autoimmune disease. * has a history of or known active brain metastases and/or carcinomatous meningitis and/or leptomeningeal metastasis * has active or uncontrolled serious infections requiring systemic therapy within 14 days prior to baseline * has a history of clinically significant cardiovascular or cerebrovascular disease in previous 6 months prior to screening * has evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis * has a seizure disorder requiring therapy (such as steroids or antiepileptics) note- additional criteria apply, please contact the investigator for more information
efficacy and safety of sparc0921 in subjects with spasticity

Conditions: Spasticity

Summary: the purpose of this study is to assess whether sparc0921 demonstrate efficacy and safety in the treatment of spasticity.


Eligibility criteria:
inclusion criteria: * men and women age 18 years and older * able and willing to comply with the protocol, including availability for a scheduled clinic visits * willingness and giving of written informed consent exclusion criteria: * in relapse or history of unstable course over the prior 30 days prior to the screening visit * concomitant neurologic conditions causing spasticity * has received an investigational drug or device within 30 days that would interfere with the study goals prior to the screening visit * unable to comply with study procedures in the opinion of the investigator

Keywords: spasticity
sapien 3 ultra eu pms

Conditions: Aortic Stenosis; Aortic Valve Stenosis

Summary: this study will evaluate real-world outcomes for the sapien 3 ultra transcatheter heart valve system in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.

this is a prospective, observational, single-arm, multicentre, post-market study.

Eligibility criteria:
inclusion criteria: 1. will undergo tavi with the edwards sapien 3 ultra system 2. less than 80 years of age at time of the procedure 3. low surgical risk 4. meets clinical and procedural requirements for early discharge 5. the subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent exclusion criteria: 1. medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship 2. considered to be part of a vulnerable population 3. active sars-cov-2 infection (coronavirus-19 \[covid-19\]) or previously diagnosed with covid-19 with sequelae that could confound endpoint assessments 4. cannot tolerate an anticoagulation/antiplatelet regimen 5. active bacterial endocarditis 6. participating in a drug or device study that has not reached its primary endpoint

Keywords: transcatheter aortic valve implantation (tavi) sapien 3 ultra thv edwards lifesciences
effects of dextromethorphan on opioid tolerance in methadone patients - 1

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to determine if addition of dextromethorphan to a stable dose of methadone in opioid dependent subjects will significantly affect physical and psychological aspects of opioid tolerance.


Eligibility criteria:
please contact site for information.

Keywords: opiate dependence
effectiveness of convalescent plasma therapy in 8 non-intubated covid-19 patients in indonesia: a case series

Conditions: Infectious Disease

Summary: this is the first case studies article highlight factors determine the effectiveness of convalescent plasma therapy (cpt) in indonesia, accompanied by supporting data and images before and after the patients received the therapy. this case studies gives a huge contribution as cpt still on going as multicentre study and apply massively as emergency approved treatment in indonesia.

eight non-intubated covid-19 patients confirmed by real-time viral rna pcr tests were included. four patients had been administered two doses of 200 ml convalescent plasma (cp) and another four patients had been administered one dose of cp with an antibody titer of 1:320. this study has three goals included to detect the improvement of patient clinical and laboratory conditions, safety of cpt, and conversion from positive to negative results after cpt administration. convalescent plasma applied within two weeks (13 days) from onset of illness and within a week (6.5 days) from the first day of hospital admission for all patients. improvements in clinical symptoms, laboratory parameters, thorax photo, negative conversion of pcr, and decreased oxygen supplementation occurred within a week after cpt. patients with two doses of cp tended to have faster recovery than those with one dose of cp. no severe adverse effects were observed in any patient. this is the first case series in indonesia showing cpt is safe and well tolerated, and early cpt before the patient is intubated could potentially prevent disease progression, increase the recovery rate, and shorten the inpatient days.

Eligibility criteria:
inclusion criteria: * covid-19 patients * severe stage * positive pcr swab exclusion criteria: * non-covid-19 patients * no symptoms covid-19 patients * mild covid-19 patients

Keywords: convalescent plasma therapy non-intubated case studies covid-19 sars-cov-2
optimization of transport and use of a mobile ecmo team in patients with sudden cardiac arrest in the moravian-silesian region

Conditions: Cardiac Arrest With Successful Resuscitation; Cardiac Arrest, Cause Unspecified

Summary: this study evaluates the feasibility of implementing a mobile extracorporeal membrane oxygenation (ecmo) team and optimizing patient transport logistics.

the aim of the study is to improve neurological outcomes in out-of-hospital cardiac arrest (ohca) cases in the moravian-silesian region. by analysing regional epidemiological and demographic data, the project aims to identify key factors for reducing the time from collapse to the initiation of ecmo and to support the development of effective protocols for extracorporeal cardiopulmonary resuscitation (ecpr).

Eligibility criteria:
inclusion criteria: * out-of-hospital cardiac arrest * indication for ecpr exclusion criteria: * death at the scene of the accident * withdrawal of the informed consent

Keywords: cardiac arrest extracorporeal membrane oxygenation out-of-hospital cardiac arrest extracorporeal cardiopulmonary resuscitation
evaluation of e2609 in subjects with mild cognitive impairment or mild dementia due to alzheimer's disease (study: e2609-a001-101 amendment 02)

Conditions: Alzheimer's Disease

Summary: subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild cognitive impairment or mild dementia due to alzheimer's disease (ad). subjects taking thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor (achei) and/or memantine for ad must be on a stable dose for at least 12 weeks prior to screening and remain on their stable dose throughout the trial. subjects will receive placebo or a single oral dose of e2609. safety assessments will be conducted. additionally, the pharmacokinetics of e2609 and drug effects will be evaluated using cerebrospinal fluid biomarkers and cognitive and psychological measures.


Eligibility criteria:
inclusion criteria: * meets the current cognitive classification of mci or mild dementia due to ad pathology (all subjects having a "positive" biomarker for amyloid β) as defined by the national institute on aging - alzheimer's association (nia-aa) research criteria * aged 50 to 85 years, inclusive at time of consent exclusion criteria: * currently has any neurological condition other than ad (alzheimer's disease)-related that could be contributing to the subject's cognitive impairment * significant pathological findings on brain mri at screening, including but not limited to multiple microhemorrhages * any psychiatric diagnosis or symptoms, e.g., hallucinations, major depression,anxiety or delusions that in the investigator's opinion could interfere with assessment of cognition or confound the diagnosis of mci or mild dementia due to ad in the subject. * a lifetime history of cerebrovascular events or non-vasovagal related loss of consciousness within the last 10 years * any other abnormality of the ecg at screening and/or baseline (including qrs \> 110 ms, abnormal electrical axis, pr interval \> 220 ms and conduction abnormalities) considered clinically significant by the investigator * history of cardiac arrhythmias, ischemic heart disease or cerebrovascular disease * lower spinal malformation on physical or lumbar spine radiography, local spinal infection, or other abnormality, including but not limited to obesity, that would prevent lp or insertion of an indwelling catheter for csf sampling * any history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (e.g., history of head trauma or concussion, previous alcohol abuse, substance abuse).
effectiveness of screening and decolonization of s. aureus to prevent s. aureus surgical site infections in surgery outpatients

Conditions: Staphylococcus Aureus Colonization; Surgical Site Infections; Healthcare Associated Infections

Summary: the purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative staphylococcus aureus (sa) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (chg) body wash, and chg mouth rinse), in eradicating sa carriage compared to other sa decolonization approaches. the study will conduct a single center pilot trial to compare efficacy of different sa decolonization approaches in pre-surgical patients, in eradicating sa carriage, after obtaining informed consent. the study will compare four different approaches, arm 1) screen for sa carriage and using the three-drug decolonization bundle for 5 days among patients with sa colonization, non sa carriers in this arm will get two pre-op showers with chg soap, arm 2) all participants receive the three drug decolonization bundle, arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with chg soap, and arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with chg soap. the primary efficacy outcome will be eradication of sa colonization at all 5 body sites. secondary outcomes will be sa surgical site infections (ssis), all ssis, and sa healthcare associated infections (hais). the study will also compare eradication of sa from each of the 5 body sites as a secondary outcome.


Eligibility criteria:
inclusion criteria: * eligible participanst are outpatients in orthopedic, urology, neuro, otolaryngology, plastic and general surgery and ob/gyn clinics who are scheduled to undergo surgery at participating trial sites. * anticipated surgery ≥ 10 days after the date of enrollment, to allow time for completion of baseline cultures and the decolonization protocol. * age ≥ 18 years * ability to complete the decolonization protocol pre-operatively as an outpatient. * no antibiotic therapy at the time of, or seven days prior to, baseline cultures, and no subsequent antibiotic therapy prior to the surgical procedure. standard pre-op antibiotic prophylaxis given. * patients are having skin incisions as part of their scheduled surgical procedure. exclusion criteria: * inability to give informed consent * surgery anticipated \<10 days after the baseline cultures
pge1 improves coronary microcirculation dysfunction in patients with cad and diabetes

Conditions: Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease

Summary: this study is undertaken to determine if intravenous lipo-pge1 therapy would improve coronary microvascular perfusion in patients with ischemic heart disease by cmri.


Eligibility criteria:
inclusion criteria: 1. patients giving written consent after being provided with sufficient explanation about participation in this clinical trial 2. patients aged between 35-70, no limitation on gender 3. patients with significant cad and no need to pci: 50%-70% luminal stenosis as determined by diagnostic coronary angiography, and left main coronary artery stenosis less than 50%; no history of revascularization procedures before 4. mpri\<2.0 5. type 2 dm patients with glycosylated hemoglobin levels\>7% 6. all patients were pge1-naive, defined as receiving no pge1 therapy for more than 7 days during the previous 12 months 7. hypertension remained stable for last 3 months, patients with controlled bp level: sbp\<160mmhg and dbp\<95mmhg exclusion criteria: 1. patients with a history of allergic to pge1 or a history of prior pge1 treatment. 2. history of revascularization procedures before: pci or cabg 3. patients with implanted pacemaker or icd, ventricular assist device and intra-aortic balloon counter pulsation pump 4. patients who have experienced myocardial infarction 5. patients with serious systolic left ventricular function failure: echocardiography ef\<25% 6. claustrophobia 7. patients who used insulin pumps 8. sbp\<90mmhg 9. chronic renal function failure: creatinine level \>2.5mg/dl or 221umol/l 10. patients with serious or frequent arrhythmia ,atrial fibrillation、frequent ventricular premature contraction、sick sinus syndrome, second- or third degree atrioventricular block 11. prior non-cardiac illness with estimated life expectancy \<2-yrs 12. women who are pregnant, lactation,or maybe pregnant in the study period 13. unable to give informed consent
safety and efficacy study of bimatoprost in ethnically japanese patients with open-angle glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically japanese patients with open-angle glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * ethnically japanese patients with glaucoma or ocular hypertension in each eye who require iop-lowering therapy in both eyes exclusion criteria: * uncontrolled systemic disease * use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (day 0)
effects of lipids on gastric emptying, satiety hormones, and appetite in severe overweight

Conditions: Effects of Lipids on Gastric Emptying; Effects of Lipids on Satiety Hormones; Effects of Lipids on Appetite

Summary: in lean subjects, free fatty acid (ffa) promotes gut hormone release, delays gastric emptying, and reduces appetite and energy intake more than an isocaloric load of triglyceride (tg). in obesity, the gastrointestinal sensitivity to food components may be reduced. in this study, the investigators compare the effects of the ffa oleic acid and the tg olive oil on gut hormone secretion, gastric emptying, appetite sensation, and subsequent energy intake in lean and severely obese subjects.

nutritional lipid within the lumen of small intestine causes a range of physiological responses that suppress appetite and reduce energy intake. thus, intestinal fat promotes the release of gastrointestinal hormones such as cholecystokinin (cck), peptide-yy (pyy) and glucagon-like peptide-1 (glp-1) that modulate gastrointestinal motility and are important for appetite regulation and food consumption. the effect of ingested fat on gut hormone secretion is highly dependent on the lipolysis of triglycerides (tgs) into free fatty acids (ffas). it has been demonstrated that adding a lipase inhibitor (tetrahydrolipstatin) to a pure fat meal accelerates gastric emptying and reduces cck release. furthermore, administration of tetrahydrolipstatin with an intraduodenal infusion of tg attenuates gastric relaxation and antro-pyloro-duodenal motility and reduces the release of cck, pyy, and glp-1 compared to tg alone. finally, intragastric administration of ffa delays gastric emptying and augments the release of cck and pyy compared to an isocaloric administration of tg. hence, the presence of ffas more than tgs within the small intestine seem to play a pivotal role in the regulation of appetite and energy intake. whereas acute intake of ffa represents a potent stimulus for suppression of appetite and energy intake, epidemiological evidence relates long-term high dietary fat intake with obesity and it is known that obese individuals prefer food with high fat content. the mechanisms behind this paradox remain unclear. however, sustained high fat-diet may change gastromotor responses and gut hormonal release to a dietary load of lipids. moreover intraduodenal sensitivity to ffa (oleic acid) was recently reported to be reduced in obese subjects. the reduced appetite and energy intake after ffas compared to tgs may, therefore, not apply to obese subjects. the aims of this study are to evaluate gastric emptying, gut hormone secretion, appetite sensation, and energy intake after isocaloric gastric administration of ffa (oleic acid) and tg (olive oil) in lean and severely obese subjects.

Eligibility criteria:
inclusion criteria: * lean subjects: bmi 20-25 * severely obese subjects: bmi \> 50 exclusion criteria: -gastrointestinal symptoms

Keywords: free fatty acid triglyceride gastric emptying satiety hormones appetite severe obesity
leukemic phase of alcl

Conditions: Anaplastic Lymphoma

Summary: collecting data about the rare leukemic presentation of anaplastic lymphoma to study the characteristics of patients with leukemic phase of alcl


Eligibility criteria:
inclusion criteria: * patients presenting a leukemic phase of anaplastic lymphoma exclusion criteria: * none

Keywords: anaplastic lymphoma leukemic phase